bvi CustomEyes Kit-AMO Germany GmbH Katarakt-set — Class II medical device recall Z-0228-2022
Ongoing recall by Beaver Visitec International, Inc., reported 2021-11-24, distributed nationwide. Product packaged as Beaver Xstar Crescent Knife, 2.5mm, 55 degrees bevel-down blades contain bevel-up blades
| Recall number | Z-0228-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beaver Visitec International, Inc., Waltham, MA, United States |
| Recall initiated | 2021-10-08 |
| Classified | 2021-11-16 |
| Reported by FDA | 2021-11-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, DE, ES, FR, GB, JP, NL, RU, ZA |
| Quantity | 500 eaches |
| UPC / GTIN / UDI-DI | 00886158112839, 30886158112830, 50886158112834 |
| Lot numbers | 3296729, 3299124, 3305081, 3307565, 3312464, 3324620, 6033588 |
| Model numbers | 373809, 588221 |
Product
bvi CustomEyes Kit-AMO Germany GmbH Katarakt-set - Dr. Wagner: CustomEyes Cataract Surgical Kits that contain Beaver Xstar¿ Crescent Knife (REF#373809) as a component a) REF# 588221 REF#: 373809
Reason for recall
Product packaged as Beaver Xstar Crescent Knife, 2.5mm, 55 degrees bevel-down blades contain bevel-up blades
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0228-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.